What randomized trials compare preoperative versus postoperative vacuum/traction protocols for IPP outcomes?
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Executive summary
Randomized data directly addressing whether preoperative versus postoperative vacuum or traction protocols yield superior outcomes after inflatable penile prosthesis (IPP) implantation are sparse: a single published randomized trial evaluated preoperative vacuum erection device (VED) use versus control and a small randomized pilot compared early postoperative daily VED to delayed on‑demand VED, but no high‑quality randomized head‑to‑head trial has definitively compared a preoperative protocol against a postoperative protocol for IPP patients [1] [2]. Systematic reviews and contemporary reviews summarize protocols and observational series that support both preoperative VED/traction and early postoperative vacuum/activation as plausible strategies, but they also emphasize heterogeneity and limited randomized evidence [3] [4] [5].
1. The one clear randomized test of preoperative VED before IPP
A randomized controlled trial by Canguven et al. tested whether daily VED use for about one month before IPP increased stretched penile length (SPL) on the day of surgery and made corporal dilation easier; the study found a statistically significant mean SPL increase of approximately 0.8 cm in the VED group and surgeon‑reported smoother corporal dilation compared with controls [1]. This trial is the principal randomized evidence supporting a preoperative VED “vacuum preparation” strategy before IPP implantation and is repeatedly cited in narrative and systematic reviews as proof of short‑term anatomical benefit [6] [7].
2. Early postoperative VED randomized pilot data exist but are limited
A small randomized pilot (Kohler and colleagues, described in reviews) assigned men to early daily VED beginning about 1 month postoperatively for several months versus late on‑demand use and reported maintenance of stretched penile length with early daily use while the late on‑demand cohort lost length (about 2 cm difference reported) — but this was a small pilot and not powered for broad practice change [2]. Larger prospective, nonrandomized series report routine postoperative vacuum regimens (e.g., twice daily for several minutes) with favorable dimensional and satisfaction outcomes, but these are observational [8].
3. Traction therapy: randomized evidence is indirect and focused on other settings
Randomized trials of modern penile traction devices (RestoreX and others) have demonstrated length gains in postprostatectomy and Peyronie’s cohorts and have been tested in randomized single‑center designs, but randomized trials specifically applying traction as a preoperative strategy before IPP are limited to pilot or nonrandomized studies; a pilot of traction before prosthesis suggested patients preserved or gained length, but it was small and not randomized at scale [9] [10]. A clinical trial registry now documents a randomized protocol using RestoreX prior to IPP to test whether device use increases implantable cylinder length, but that trial (NCT07053826) is registered and results are not yet available in peer‑reviewed form [11].
4. What systematic and contemporary reviews conclude about RCT evidence
Recent reviews and systematic assessments summarize many perioperative strategies (preoperative VED, traction therapy for months preop, intraoperative techniques, and postoperative early activation or daily inflation), concluding that preoperative VED and traction and postoperative vacuum/early inflation are plausible interventions to preserve or improve penile dimensions, but they consistently note that high‑quality randomized head‑to‑head trials comparing preoperative versus postoperative protocols for IPP outcomes are lacking [3] [4] [5]. The literature thus contains RCTs testing single interventions (preop VED, early vs late postop VED in pilots) and randomized traction trials in other surgical populations, but not a definitive randomized comparison of “preop VED/traction” versus “postop VED/traction” across adequately powered IPP cohorts [1] [2] [10].
5. Practical implications and research gaps
Clinicians and patients must balance encouraging signals from a small RCT for preoperative VED and pilot postoperative VED data against the reality that no large randomized head‑to‑head trial exists to declare one timing strategy superior for long‑term penile dimensions, functional satisfaction, or complication profiles after IPP [1] [2] [8]. Ongoing registered studies testing preoperative traction devices (RestoreX) may fill part of this gap, but until randomized, adequately powered comparative trials are published, recommendations rely on lower‑level evidence, expert opinion, and institutional protocols described in reviews [11] [3] [4].